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NCT00671931 · ClinicalTrials.gov registry record · Phase 1
Susceptibility of Motor-Evoked Potentials to Varying Targeted Blood Levels of Dexmedetomidine
A Phase 1 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
NCT00671931 is a Phase 1 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 44 participants.
The verdict
NCT00671931, a Phase 1 study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
Study Summary
Reduction of the spinal cord injuries during scoliosis surgery is a major goal of the anesthesia and surgical team. Despite improvement in scoliosis surgery over the years, the development of neurological deficits remains the most feared complication of spine surgery. During scoliosis surgery it is very important to monitor the spinal cord to detect spinal cord injury with surgical manipulation. Continuous or intermittent intraoperative electrophysiological monitoring (neuron-monitoring) is used routinely during these procedures to provide the surgeon with information concerning the integrity of neurological structures at risk. All neuron-monitoring modalities are affected by the anesthetic regimen used. Of the various intravenous anesthetic drugs, the combination of propofol, remifentanil and dexmedetomidine appear to impact neuron-monitoring the least. The current anesthetic practice is to use the three drugs in combination at doses that do not depress the signals but there is no data relating targeted dexmedetomidine and propofol blood levels to neuron-monitoring signals. The lack of data results in wide variability in dosing with consequent variability in patient response. Hypothesis: Clinically relevant blood levels of dexmedetomidine will affect the amplitude of transcranial motor-evoked potentials (TcMEP) either independently or by interaction with propofol in a dose dependent manner.
Interventions
- DRUG Dexmedetomidine
- DRUG low dexmedetomidine, low propofol
- DRUG high dexmedetomidine, low propofol
- DRUG Dexmedetomidin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2007-04 |
| Est. Completion | 2009-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00671931
The ClinicalTrials.gov registry entry for NCT00671931 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Dexmedetomidine is the first listed.
NCT00671931 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00671931 about?
NCT00671931 is a clinical study titled "Susceptibility of Motor-Evoked Potentials to Varying Targeted Blood Levels of Dexmedetomidine". Reduction of the spinal cord injuries during scoliosis surgery is a major goal of the anesthesia and surgical team. Despite improvement in scoliosis surgery over the years, the development of neurological deficits remains the most feared complication of spine surgery. During scoliosis surgery it is ...
What is the current status of trial NCT00671931?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2007-04. Estimated completion is 2009-01.
What interventions are being tested in trial NCT00671931?
The interventions under investigation include: Dexmedetomidine (DRUG), low dexmedetomidine, low propofol (DRUG), high dexmedetomidine, low propofol (DRUG), Dexmedetomidin (DRUG).
Who is sponsoring clinical trial NCT00671931?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
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